The EVARREST® Fibrin Sealant Patch Liver Study

A Phase III Randomized, Controlled, Superiority Study Evaluating EVARREST® Fibrin Sealant Patch Versus Standard of Care Treatment in Controlling Parenchymal Bleeding During Hepatic Surgery

To evaluate the safety and hemostatic effectiveness of EVARREST® Fibrin Sealant Patch (EVARREST) versus standard of care treatment (SoC) in controlling parenchymal bleeding during hepatic surgery.

Inclusion Criteria:

• Subjects ≥ 18 years of age, requiring elective or urgent, open hepatic surgery.
• Presence of an appropriate bleeding hepatic parenchymal Target Bleeding Site (TBS) as identified intra-operatively by the surgeon
• Subjects or legally authorized representatives must be willing to participate in the study, and provide written informed consent. (Note: This criteria does allow for hospital translators to be used where approved by Ethics Committees/Institutional Review Boards)

Exclusion Criteria:

• Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
• TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST® to blood flow and pressure during healing and absorption of the product;
• TBS with major arterial bleeding requiring suture or mechanical ligation;
• Subjects admitted for trauma surgery;
• Subject is a transplant patient for fulminant hepatic failure
• Subject with TBS within an actively infected field;
• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine;
• Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
• Subjects who are known, current alcohol and / or drug abusers;
• Subjects who have participated in another investigational medical device or investigational drug trial within 30 days of surgery or are expected to participate in another medical device or investigational drug trial during the course of the study;
• Female subjects who are pregnant or nursing.